Ask someone how they reached a hard health decision and they rarely describe a leaflet. They did their research, spoke to experts, weighed the pros and cons, and very often the most useful thing was hearing from someone who had been through a similar experience and could speak honestly about what it felt like.
Studies on patient decision aids show that narrative accounts from people with lived experience shape decisions differently from statistics alone (Dillard, Fagerlin, Zikmund-Fisher et al., 2010). Real stories help people imagine what an outcome will actually feel like day to day. This is often called narrative evidence, and it is considered a legitimate complement to clinical and statistical information.
“People trust lived experience because it answers a question that data cannot: what does this actually feel like in practice.”
For many people considering a clinical trial, that conversation starts with those closest to them, their guardian, spouse, family member and then it may widen to reaching out to a community. Long before anyone speaks to a site coordinator or reads a consent form, these early conversations are already shaping how the decision feels, what questions seem important, and whether participation seems possible.
The question I propose needs answering is this:
How do we recognize this and build it into the process in a more deliberate way?
Readiness is not a solo act
This process happens inside a person, and it is also shaped by everything around them: the relationships they are in, the information they have been able to access, and the stories they have heard.
This is especially true in rare disease communities. When a condition affects a small number of people, the community of others who share it becomes an important information network. People find each other, share what they have learned, and pass on knowledge about trials, about what participation involves, and about what helped and what was harder than expected (Wheeden et al., 2025). This is informal readiness work, happening constantly, without formal structure or recognition.
A 2018 systematic review published in the BMJ found that patient and public involvement in clinical trials was associated with significantly better enrollment and retention outcomes (Crocker et al., 2018). When people feel connected to others who understand their situation and can see that others like them have made this decision and been supported through it, participation becomes something they can imagine for themselves.
That shift in imagination is a readiness shift and it happens through community.
What communities already offer that the system cannot
An important paper published in The Lancet Global Health in April 2025, developed with the support of the World Health Organization, made the case for sustained, meaningful engagement with patients, the public, and communities throughout the full lifecycle of a clinical trial (Gobat et al., 2025). There is also a more personal layer beneath that structural argument: what communities contribute to the individual person making a decision.
- Communities offer honest, experiential accounts of what participation actually looks like: what it felt like to attend visits, to manage the schedule alongside family and work, to sit with uncertainty about whether the treatment was working. A person who has heard from someone in their community about what a typical study week involved is in a fundamentally different position from someone who has only read a leaflet.
- Communities offer emotional normalization. The fear of joining a trial, the uncertainty about whether to trust the research team, the guilt of considering something that might take time away from family: these are very human feelings and they can feel isolating. When someone learns that others in their community have felt the same things and still found a way to decide, the weight of those feelings changes. They become part of the process rather than a barrier to it.
- Communities offer the permission to say no. A community of peers who can say honestly that they chose not to participate, or that they withdrew, or that the timing was not right for them, makes the full range of choices feel available. That is the foundation of genuine, informed consent.
The gap: communities are invisible in the formal readiness process
Despite the influence communities have on individual decision-making, the formal clinical trial process almost never makes space for them at the point of consent. The community, which has often been doing readiness work for weeks or months before that moment, is invisible in the formal record.
Failure to engage individuals, the public, and community stakeholders comes at a cost. There are considerable negative effects on trust in science, in research regulation, and in the products themselves (Gobat et al., 2025).
What an embedded community model could look like
If communities are already doing readiness work informally, the question is how to make that involvement more deliberate and more useful. Some practical ideas include the following.
Trained peer navigators: people with lived experience of trial participation who are available to speak with people considering taking part, offering an honest account of what participation involves and what questions are worth asking. This kind of support has already been shown to strengthen both the quality of consent and the sustainability of participation (Gobat et al., 2025).
Ensuring that readiness self-reflection tools are shared with community networks as well as with individuals, so that patient advocacy groups and peer support organizations can help people approach them thoughtfully. A person who has talked through the six areas with a peer advocate before working through the tool is likely to engage with it very differently from someone who encounters it for the first time alone.
At the site level, for those people taking the step into a clinical trial, teams actively asking who the person has spoken to in their community about this decision and what they have heard makes a real difference to how that person can be supported through the process.
Feeding information back to communities after trials are complete, as a genuine contribution to the collective readiness of future participants. Communities that understand the outcomes of trials their members have joined are better placed to support the next person facing the same decision.
Closing Thoughts
Readiness for a clinical trial is something a person arrives at, though they do not arrive at it alone. The community around them shapes how they understand the decision, how they feel about it, and whether they can imagine themselves saying yes and following through. The clinical trial system has been slow to recognize this, as community engagement has been conceived primarily as a tool for better trial design and broader recruitment. There is a more immediate role for community in the readiness of each individual person at the moment of decision.
The Author
Dr Angelika Grechnaya is a qualified counseling psychologist and Psychology & Behavioral Insights Lead at trialport. Her work draws on cognitive behavioral therapy, psychodynamic therapy and existential analysis, with a particular interest in how people navigate uncertainty, emotional pressure and significant life decisions. At trialport, she applies behavioral science to help make clinical trial information and decision-making clearer, more human and better grounded in the realities of people’s lives.
trialport
readifit™ is a self-reflection tool developed by trialport to help a person consider whether a particular clinical trial could work within the realities of their life. It explores areas including understanding, emotional readiness, practical demands, support and personal values. It sits alongside medifit™, which helps people consider possible medical suitability in plain language. Neither tool determines eligibility or replaces discussion with a research site. Their purpose is to help people approach that conversation better informed and with the questions that matter to them.
https://trialport.com/medifit-readifit/
If you support a patient community and want to see how these early conversations can be part of the pathway, see how trialport works with communities and advocacy groups.
References
Crocker, J. C., Ricci-Cabello, I., Parker, A., Hirst, J. A., Chant, A., Petit-Zeman, S., Evans, D., & Rees, S. (2018). Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis. BMJ, 363, k4738. https://doi.org/10.1136/bmj.k4738
Dillard, A. J., Fagerlin, A., Dal Cin, S., Zikmund-Fisher, B. J., & Ubel, P. A. (2010). Narratives that address affective forecasting errors reduce perceived barriers to colorectal cancer screening. Social science & medicine, 71(1), 45-52. https://doi.org/10.1016/j.socscimed.2010.02.038
Gobat, N., Slack, C., Hannah, S., Salzwedel, J., Bladon, G., Burgos, J. G., Purvis, B., Molony-Oates, B., Siegfried, N., Cheah, P. Y., Conway, M., Kamuya, D., Davies, A., Johnson, T., Tholanah, M., Mugamba, S., Mutengu, N. L., Machingaidze, S., Schwartz, L., & von Harbou, K. (2025). Better engagement, better evidence: working in partnership with patients, the public, and communities in clinical trials with involvement and good participatory practice. The Lancet Global Health, 13, e716-e731. https://doi.org/10.1016/S2214-109X(24)00521-7
Wheeden, K., Meyers, S., Anthony, K., Chehade, M., Gifford, R. C., King, E. C., & Seid, M. (2025). Enhancing and leveraging principal investigator and patient advocacy group collaboration in rare disease clinical research-meeting report from the rare Diseases Clinical Research Network. Therapeutic Advances in Rare Disease, 6, https://doi.org/10.1177/26330040251357318
About the author
Keith Berelowitz has spent more than twenty years watching clinical trials work on paper and struggle in real life. He has helped run studies, advises sponsors and CROs on how they engage with people, and chairs a UK research ethics committee, where consent forms and participant information sheets cross his desk every month. That vantage point led to one conclusion: most trial problems are not failures of science. They are failures of understanding at the moment a person decides.
He founded trialport, a clinical trial navigation and decision-support platform, to help people weigh a trial in the context of real life rather than on paper alone. Its medifit™ + readifit™ self-reflection tools ask two questions: Is this trial right for my health? Is this trial right for my life? Understanding comes first. Decisions follow.